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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00460486 |
The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
Condition | Intervention | Phase |
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Encephalitis, Tick-Borne |
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older |
Estimated Enrollment: | 330 |
Study Start Date: | September 2006 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if they:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
Poland | |
Centrum Badan Farmakologii Klinicznej monipol | |
Krakow, Poland, 30-969 | |
"PANTAMED" Sp. z o.o. | |
Olsztyn, Poland, 10-461 | |
Niepubliczny ZOZ "Atarax" s.c. | |
Olsztyn, Poland, 10-117 | |
Niepubliczny ZOZ "VITA" | |
Olsztyn, Poland, 10-295 |
Principal Investigator: | Baxter BioScience Investigator, MD | Baxter BioScience |
Responsible Party: | Baxter Healthcare Corporation ( Katrin Koelling Schlebusch, Clinical Project Manager ) |
Study ID Numbers: | 690601 |
Study First Received: | April 13, 2007 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00460486 |
Health Authority: | Poland: Ministry of Health |
Virus Diseases Central Nervous System Infections Formaldehyde Central Nervous System Diseases Healthy |
Arbovirus Infections Brain Diseases Tick-Borne Diseases Encephalitis Encephalitis, Tick-Borne |
Encephalitis, Viral Anti-Infective Agents Disinfectants RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Therapeutic Uses Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus Pharmacologic Actions |